FDA.reportPublic FDA data

LensHooke Liquefaction Enzyme

Primary DI
04719874741259
Brand
LensHooke Liquefaction Enzyme
Company
BONRAYBIO CO., LTD.
Model
CK1 Package-10pcs-BR USA CORP.
Catalog number
CK1
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IBGTrypsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBGTrypsinPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874741259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874741259047198747412594719874741259

GMDN Terms#

Term, Definition table
TermDefinition
Specimen preparation enzyme reagent IVDAn enzymatic substance or reactant intended to be used alone or in combination with other IVDs for the liquefication or digestion of clinical laboratory specimens containing mucoid or clumped material in preparation for further processing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658872369
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14719874742680LensHooke Semen Quality AnalyzerX3 PRO SEX3 PRO SE2026-04-23
14719874743502LensHooke Semen Test SlideCS3-01 Package-25pcs-US-HTCS3-01 10um2026-02-06
14719874743519LensHooke Semen Test SlideCS3-01 Package-25pcs-US-BRCS3-01 10um2026-02-06
14719874743526LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay)R11 Plus-01 Package-10 tests-US-BRR11 Plus-012026-02-06
14719874743533LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)R11 Plus-01 Package-10 tests-US-HTR11 Plus-012026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-BRR10 Plus-012026-02-06
14719874743571LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-HTR10 Plus-012026-02-06
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-BRR10 Plus2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-HTR10 Plus2025-02-16
14719874743458LensHooke Semen Analysis SystemX12 Package-1pcs-US HT(Plug UL)/RXX12 PRO2025-09-01
14719874743465LensHooke Semen Analysis SystemX12 Package-1pcs-US BR(Plug UL)/RXX12 PRO2025-09-01
24719874742267LensHooke Sperm Separation DeviceCA0 Package-150 sets-EN-CECA02025-04-10
14719874742222LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-HTCA12025-02-16
14719874742239LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-HTCA02025-02-16
14719874742253LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-BRCA02025-02-16
14719874742284LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-BRCA12025-02-16
24719874742250LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-BRCA02025-02-16
24719874742236LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-HTCA02025-02-16
04719874741242LensHooke Liquefaction EnzymeCK1 Package-10pcs-US HTCK12025-02-16
04719874741303LensHooke Semen Quality AnalyzerUL-US-X1.E206X1 PRO2025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874741242LensHooke Liquefaction EnzymeBONRAYBIO CO., LTD.IBG2025-02-16
07290012140150QwikCheck LiquefactionM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.IBG2023-06-08
04015630971138PROTEASE 1Ventana Medical Systems, Inc.IBG2021-01-29
04015630971145PROTEASE 2Ventana Medical Systems, Inc.IBG2021-01-29
04015630971152PROTEASE 3Ventana Medical Systems, Inc.IBG2021-01-29
04015630971862ISH PROTEASE 1Ventana Medical Systems, Inc.IBG2021-01-29
04015630971879ISH PROTEASE 2Ventana Medical Systems, Inc.IBG2021-01-29
04015630971886ISH PROTEASE 3Ventana Medical Systems, Inc.IBG2021-01-29